A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM)

NCT05240612 | Completed Phase 1

• 2 other identifiers: MT-3921-C-101jRCT2031210616
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study is to assess the safety, tolerability, and pharmacokinetics of MT-3921 in subjects with Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy(HAM). Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.

Conditions

HTLV-1-Associated Myelopathy (HAM)

Outcome Measures

Primary Outcomes (4)

• Percentage of subjects with adverse events

  36 weeks

• Percentage of subjects with adverse reactions

  36 weeks

• Serum concentrations of MT-3921

  PK samples will be collected at predose, 1.5 hours, 2, 4, 8, 12, 20 (predose and 1.5 hours), 24, 36 weeks post-dose.

• CSF concentrations of MT-3921

  PK samples will be collected at 2, 4, 12, 24 weeks post-dose.

Study Arms (2)

MT-3921

EXPERIMENTAL

Intravenous (IV)

Biological: MT-3921

Placebo

PLACEBO COMPARATOR

Intravenous (IV)

Biological: Placebo

Interventions

MT-3921 BIOLOGICAL

Solution for infusion; Intravenous (IV)

Also known as: Unasnemab

MT-3921

Placebo BIOLOGICAL

Solution for infusion; Intravenous (IV)

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Additional screening criteria check may apply for qualification:
• Subjects aged 20 years or older on the day of consent
• Subjects with a confirmed diagnosis of HAM according to the diagnostic algorithm of Practical Guideline for HAM 2019 on the day of consent
• Subjects with an Osame's motor disability score (OMDS) of ≥4 and ≤6 at Screening and on the first day of the Treatment period (predose)
• Subjects with no change in OMDS for at least 3 months before the day of consent
• Subjects with a CSF concentration neopterin of ≥6 pmol/mL at Screening
• Subjects on maintenance oral steroid therapy who have continued to receive the same dose equivalent to ≤10 mg/day of prednisolone for at least 3 months before the day of consent

You may not qualify if:

• Additional screening criteria check may apply for qualification:
• Subjects who have a history of anaphylaxis or clinically significant allergic reactions due to administration of antibody products
• Subjects exhibiting or with a history of malignant tumor.
• Subjects with adult T-cell leukemia/lymphoma (ATL) or those with positive HTLV-1 clonality test (Southern blot) at screening and suspected of having ATL
• Subjects with spinal cord compression lesions, such as cervical spine disease, disc herniation, and ossification of the yellow ligament
• Subjects with psychiatric disorders, epileptic seizures, or dementia.
• Subjects with suicide attempts or suicidal ideation corresponding to item 4 or 5 on the Columbia Suicide Rating Scale (C-SSRS) at screening and/or on the first day of the Treatment period (predose)
• Subjects exhibiting or with a history of hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection.
• Subjects with the novel Coronavirus disease 2019 (COVID-19)
• Subjects with severe illness
• Male or female subjects of childbearing potential who do not agree to use a contraceptive measure from the day of consent to 16 weeks after the last dose of the investigational medical product
• Female subjects who are pregnant, lactating, or may be pregnant
• Subjects who have received anti-repulsive guidance molecule (RGM) a antibody containing this investigational medical product
• Subjects who participated in other clinical studies (including clinical trials) and received drugs (including investigational medical products) or therapy within 12 weeks before the day of consent

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

St. Marianna University Hospital

Kawasaki-shi, Kanagawa, 216-8511, Japan

Location

MeSH Terms

Conditions

Paraparesis, Tropical Spastic

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; HTLV-I Infections; Deltaretrovirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2022
• First Posted: February 15, 2022
• Study Start: May 2, 2022
• Primary Completion: September 14, 2023
• Study Completion: December 28, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)